Mammographic Density and Soy Isoflavones
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Fibroglandular Tissue in Total Breast (FGBT%)
研究概览
简要总结
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
详细描述
This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol.
Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.
入排标准
- 年龄范围
- 30 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy premenopausal women
- •30 to 42 years old
- •normal mammograms
- •regular menstrual cycles
排除标准
- •abnormal mammograms
- •first degree relatives with breast cancer
- •pregnant or lactating
- •peri- or post-menopause
- •breast augmentation, reduction or lifting
- •on oral contraceptive medications or exogenous hormones
- •medically prescribed diets
- •allergic reaction to soy products
结局指标
主要结局
Fibroglandular Tissue in Total Breast (FGBT%)
时间窗: baseline, and after year 1 and 2 of supplementation
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
Breast Density by Mammography
时间窗: baseline, and after year 1 and 2 of supplementation
Area of FGBT in mammogram. The timepoints were combined and summed.
次要结局
- Bone Mineral Density(one and two years after dietary supplement)